Below you will find basic demographic and healthcare market data on Mexico, plus specific information about the medical device and healthcare industries.

Overview of medical device industry: Mexico is the second largest medical device market in Latin America, following Brazil. With increasing health expenditure and the acquisition of new technology, Mexico is the leading medical importer in Latin America. It was valued at US$4 billion in 2015 but projected growth is modest; the market will increase to US $5.5 billion by 2020.

Imports make up nearly 90% of the medical devices sold in Mexico. Mexico imports medical devices from all over the world, with the most devices coming from the United States, Asia, and throughout Europe. However, there is a small medical device manufacturing industry concentrated in Baja California, a region that accounts for 36% of medical device exports and is home to more than 60 companies.

Industry challenges in Mexico: Regulatory timeframes are one of the biggest obstacles to entering the Mexican market. Even though COFEPRIS, the regulatory body in Mexico, has several registration routes available, submission process in time consuming and approval can take months, resulting in a backlog of submissions. However, COFEPRIS is working to refine its registration process for medical devices. In addition, importers can expect fierce competition from US manufacturers, which control more than 50% of the Mexican import market.

Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Learn more here.